Sunday, March 10, 2013

My Opinion: Tredaptive® THRIVE Outcomes Unfortunate But Won't Hurt Merck Stock Much

While this weekend's ACC full disclosure of all the unfortunate findings and observations from HPS2-THRIVE study of about 25,000 patients are disappointing, it should not result in any significant down-draft in Merck's NYSE price on Monday. Almost all of this information was known (or highly-suspected) prior to this weekend (at least in terms of its likely small financial impact on Merck), and the Abbott niacin combo pill (called Niaspan®) had long ago suffered somewhat similar set-backs.

[As to that would-be contingent Merck financial exposure however, here in the US, it should be kept in mind that there cannot be a class of complaining patients (against Merck), as Tredaptive® was never approved by FDA. And we all know that the lion's share of all drug product liability flows from US complaints. It will be a tall order, in my opinion, in the EU and elsewhere, to win any damages against Merck, on these facts.]

So, continuing my minor digression here -- if US patients were treated with niacin combinations, their complaints (whatever those might be) lie solely with their treating physician(s), not the drug manufacturer(s), per se -- primarily Abbott and Merck. Any non-approved or off-label therapies administered are solely the responsibility of the treating physician, under applicable US law. Especially so, where the data rolling out -- ever since 2008 -- gives these same physicians ample reason to reconsider the niacin notion. [If Merck or Abbott touted the niacin combos (as unapproved drugs) to US physicians, however, that would be a completely different matter. So far, we've seen no evidence of that, and the EU with its single payer scheme generally makes recoveries against drug makers far more difficult than what we are used to, here in the US. Malpractice claims against providers face higher hurdles in the EU -- and drug company (manufacturer) settlements are fairly rare.]

To be clear, I do not mean to seem callous to the plight of these arguably affected non-US patients, but one might look upon this episode as proof that the FDA here in the United States usually "gets it right". See, the FDA never approved Tredaptive -- quite rightly, it turns out, asking for more data of safety and effectiveness -- from April of 2008 on. At the same time, I don't fault the EMEA, either -- it simply moved forward, in July of 2008, to allow yet another treatment option to be placed in the hands of Europe's very capable treating physicians. Now that that all the blinded data are out, it was also wise that Merck voluntarily withdrew Tredaptive, globally, back in early January of 2013.

Here is a bit of the Reuters weekend story -- do go read it all:

. . . .When it was announced that the drug called Tredaptive had failed to prevent heart attacks, strokes, death and other complications in heart patients also taking drugs to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and would stop selling it in the dozens of other countries where it was already available . . .

[THRIVE] Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent vs 1.9 percent - and infections - 8.0 percent vs 6.6 percent - that they called unexpected.

Significantly higher numbers of patients taking Tredaptive also experienced serious health problems that researchers called known side effects of niacin. Those included new onset diabetes - 9.1 percent vs 7.3 percent - diabetic complications - 11.1 percent vs 7.5 percent - and gastrointestinal problems - 4.8 percent vs 3.8 percent.

Niacin, a form of vitamin B, has been used for many years in the belief that its HDL raising powers would help prevent heart attacks and strokes.

Professor Jane Armitage, who led the study called HPS2-Thrive, called the findings disappointing.

"Still," she said, "finding out a drug is not helping people is just as important as finding that it has benefits. . . ."

Since Merck is one of the most widely-held, and deeply traded securities on the NYSE, it shouldn't take too long on Monday morning for the crowd wisdom to protect Merck's price -- should some pre-market selling pressure appear on the NASDAQ before 9:30 EST on Monday.

Don't get suckered -- that's my advice -- but do your own diligence. I hold no position in Merck or Abbott, at the moment. I just don't like seeing people make an easy buck off of largely-baseless financial fear-mongering.

No comments: